Allena Pharmaceuticals Announces Presentation of Successful Phase 2
Data from ALLN-177 Program at American Society of Nephrology Kidney Week

November 12, 2015 07:03 AM Eastern Time

NEWTON, Mass.--(EON: Enhanced Online News)--Allena Pharmaceuticals, Inc., a specialty biopharmaceutical company
focused on developing and commercializing innovative non- systemic oral
protein therapeutics to treat metabolic and orphan diseases, presented
successful results from the first Phase 2 trial of ALLN-177
(NCT02289755) at the American Society of Nephrology (ASN) Kidney Week
2015 on Saturday, November 7th. ALLN-177 is currently being developed
for the treatment of secondary hyperoxaluria in patients with a history
of calcium oxalate kidney stones. Treatment with ALLN-177 resulted in a
statistically significant reduction of urinary oxalate excretion in
patients with secondary hyperoxaluria (p = 0.0084). The study also
showed that ALLN-177 was well tolerated in the target patient
population. Based on this positive Phase 2 data, the company has
initiated two additional Phase 2 clinical trials of ALLN-177 in patients
with secondary hyperoxaluria (NCT02503345, NCT02547805).

“We are encouraged by the positive Phase 2 results in patients with
secondary hyperoxaluria and a history of calcium oxalate kidney stones,
which builds on the previously presented proof-of-concept data on
reduction of urinary oxalate excretion in healthy volunteers”

“Presently there are no effective treatments for hyperoxaluria. This
study provides direct evidence that ALLN-177 can produce a statistically
significant reduction in urinary oxalate excretion in patients with
hyperoxaluria,” said study presenter Craig B. Langman, M.D., the Isaac
A. Abt M.D. Professor of Kidney Diseases at Feinberg School of Medicine,
Northwestern University and Head, Kidney Diseases at Lurie Children's
Hospital of Chicago. “Hyperoxaluria is a major risk factor for kidney
stones, and lowering urinary oxalate excretion is a therapeutic goal in
patients with calcium oxalate kidney stones. ALLN-177 meaningfully
reduced urinary oxalate excretion, and the magnitude of reduction
directly correlated with the severity of hyperoxaluria.”

The Phase 2, single-arm, open-label study evaluated the safety and
efficacy of orally administered ALLN-177 in sixteen kidney stone
patients with elevated urinary oxalate excretion despite standard
medical therapy. ALLN-177 was shown to significantly and substantially
reduce mean urinary oxalate levels (mg/24 hours) from baseline (p =
0.0084). Urine oxalate decreased from a mean at baseline of 77.6 to 63.7
mg/24 hours, a decrease of 13.9 mg/24 hours (or 13.3%), and 50% of
subjects had a decrease in urinary oxalate by at least 10 mg/24 hours.
Greater decreases in urinary oxalate excretion were observed in subjects
with higher levels of urinary oxalate at baseline. A post-hoc analysis
showed that ALLN-177 also significantly reduced the relative
supersaturation index of calcium-oxalate, which correlates with the
tendency to form crystals, from 11.6 to 8.8 (p <0.05). ALLN-177 was well
tolerated, with no serious or significant adverse events reported, and
all subjects completed the full course of treatment.

“We are encouraged by the positive Phase 2 results in patients with
secondary hyperoxaluria and a history of calcium oxalate kidney stones,
which builds on the previously presented proof-of-concept data on
reduction of urinary oxalate excretion in healthy volunteers,” said
Louis Brenner, M.D., chief operating officer at Allena Pharmaceuticals.
“There are no specific pharmacologic treatments available for the
treatment of hyperoxaluria, so we are excited to advance the development
of ALLN-177 with our two additional ongoing Phase 2 trials.”

About Hyperoxaluria and ALLN-177

Hyperoxaluria is a condition resulting from high oxalate levels in the
urine due to either hyper-absorption of oxalate from the diet
(secondary) or from overproduction of oxalate by the liver (primary) due
to a genetic defect. Oxalate is a terminal metabolite that cannot be
further degraded by humans and is primarily excreted by the kidneys.
Hyperoxaluria can initially cause the development of kidney stones, and
may also lead to kidney damage (nephrocalcinosis), chronic kidney
disease, end-stage renal disease and dialysis. Calcium oxalate is the
most common constituent of kidney stones. There are currently no
approved pharmacologic treatments for hyperoxaluria.

ALLN-177 is an orally-administered, recombinant oxalate-degrading enzyme
in development for the chronic management of hyperoxaluria and kidney
stones (nephrolithiasis). ALLN-177 targets oxalate in the
gastrointestinal tract, in an effort to reduce the burden of both
dietary and endogenously produced oxalate. ALLN-177 has the potential to
decrease the oxalate available systemically for deposition as calcium
oxalate crystals or stones in the kidneys, as well as reduce the
incidence of calcium oxalate related complications. Effective management
of hyperoxaluria could reduce long-term kidney complications, as well as
the number of interventions required for the management of kidney stones.

Allena is presently conducting two additional Phase 2 trials in the
United States for calcium oxalate kidney stone patients with
hyperoxaluria. The first trial (NCT02503345) is a double-blind,
placebo-controlled crossover dose-ranging study. The second trial
(NCT02547805) is a double-blind, placebo-controlled parallel design
study of 28 days duration.

About Allena Pharmaceuticals

Allena Pharmaceuticals, Inc. is a specialty biopharmaceutical company
focused on developing and commercializing non-systemic protein
therapeutics to treat metabolic and orphan diseases. Allena’s lead
program, ALLN-177, is currently conducting two additional Phase 2
clinical trials in patients with hyperoxaluria. The company’s
technological approach enables the design and development of oral
protein therapies that remain in the gastrointestinal (GI) tract, where
the protein exerts its therapeutic effect by degrading metabolites,
without being absorbed into the bloodstream. Led by a proven management
team with deep expertise in protein therapeutic design and development,
Allena is committed to bringing breakthrough new treatments to patients
with unmet medical needs. Based in Newton, Mass., the company is backed
by top-tier venture investors including Frazier Healthcare, Third Rock
Ventures, HBM Partners, Bessemer Venture Partners and other investors.
For more information, please visit www.allenapharma.com.